Treatment Resistant DepressionNCT05355142
An Intervention Study of Anhedonia and Pain Empathy in Depression
A study testing PM+ in people with Treatment Resistant Depression and Problem Management Plus, run by Anhui Medical University at 1 site in China.
Trial summary
Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Treatment Resistant Depression, Problem Management Plus, Event-Related Potentials
- What is being tested?
- PM+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- College students;
- PHQ-9 > 4 points;
- After informing the content of the study, agree to join the study, sign the informed consent form and accept relevant examination;
- No major physical diseases in the past;
Who cannot join
- Lack of basic data;
- Those who are currently diagnosed with depression and receiving psychotherapy;
- Those who are unwilling to accept the inspection and quit halfway;
- History of brain trauma, or accompanied by serious physical diseases, such as heart and liver dysfunction;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230032
Fengqiong Yu, MD, yufengqin1@163.com
About this study
Official title: Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention
Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention.
Read the detailed description
It is expected to collect 66 college students.
- Depressed college students；Healthy control: Inclusion criteria: 1) college students; 2) PHQ-9 > 4 points; 2) After informing the content of the study, agree to join the study, sign the informed consent form and accept relevant examination; 3) No major physical diseases in the past; Exclusion criteria: 1) lack of basic data; 2) Those who are currently diagnosed with depression and receiving psychotherapy; 3) Those who are unwilling to accept the inspection and quit halfway; 4) History of brain trauma, or accompanied by serious physical diseases, such as heart and liver dysfunction;
- Scale evaluation: 2.1 background information: gender, age, years of education, marriage and childbirth, place of residence (urban and rural), family economic situation (poor, general and good), family structure (core, single parent, reorganization and separation), self-rated learning pressure (high, general and low), whether he is an only child and whether he is a class cadre, etc. 2.2 depression assessment: Depression Screening Scale (PHQ-9), 2.3 symptom evaluation of loss of pleasure: time experience pleasure scale (TEPS); Loss of social pleasure (RSAs) 2.4 UCLA Loneliness Scale; TAS Alexithymia Scale; Chinese version of interpersonal response index scale (IRI)
- Experimental paradigm was measured before and after psychological intervention 3.1 Intensive delay First, the subjects were presented with a signal indicating that the cue was 400ms. After cue, the fixation point was 2250-2750 MS, and then the target stimulus square appeared. The presentation time was 160 ms to 260 Ms. The subjects are required to respond to the target stimulation key at the fastest speed. The time of random presentation of fixation is 1450ms. The feedback signal is given according to the results of the subjects' key response, and the presentation time is 1650ms. Finally, the fixation point was presented for 1200-1500ms; The whole paradigm includes two types of reward tasks; One is monetary reward and the other is social reward. Each task consists of 88 trials, resulting in a total of 176 trials. 3.2 Experimental paradigm of pain empathy In the experiment, the screen first presents a 400ms "+" fixation point, then presents a 400ms empty screen, and then presents a 1000ms picture stimulus. After the stimulus is presented, the empty screen is 1500 ~ 1700ms. The experiment consists of two tasks: ① pain judgment task, which requires subjects to judge whether the body owner in the picture will feel pain ② Left right judgment task: the task requires the subjects to distinguish the left and right limbs in the picture. The subjects also need to watch the picture carefully and make a judgment as quickly and accurately as possible。
- PM + (problem management plus) intervention is a psychological intervention of 1.5 hours each time for five weeks. Four strategies are mainly taught so that students can use them in daily life. PM + includes four core strategies: (1) decompression (breathing relaxation, mindfulness, etc.); (2) Problem management (coping strategies for practical problems); (3) Act by words, persevere, and emphasize behavior activation (mainly for the strategy of withdrawal of depressive behavior); (4) Strengthen interpersonal relationships (emphasis on strengthening interpersonal connections).
- Being tested
- PM+
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM+Behavioural
1 Brief introduction to PM+ \& NDA (5 min) Assessment-based review with PSYCHOLOPS (psychopomps psychology ) assessment (10 min) What is PM+ (20 minutes) Understanding Adversity (30 minutes) Stress Management (20 minutes) Closing the meeting (5 minutes)
2 General Review (5 min) Issue management (70 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)
3 General Review (5 minutes) Problem Management (35 minutes) Take action and be consistent (35 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)
4 General Review (5 minutes) Issue Management (20 minutes) Take action and be persistent (20 minutes) Strengthening Social Support (30 minutes) Stress management (10 minutes) Closing the meeting (5 minutes)
5 General Review (20 minutes) Staying Healthy (30 minutes) Imagining how to help someone (20 minutes) Looking ahead (15 minutes) Closing the de-briefing (5 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Group PM+ | Experimental | Intervention once a week for a total of 5 weeks Receives: Behavioral: PM+ |
| control group | No intervention | Just daily observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Patient Health Questionnaire
The four-level scoring of the PHQ-9 Depression Screening Scale, consisting of nine items with a total score of 0-27, where 0-4 is no depression, 5-9 may have mild depression, 10-14 may have moderate depression, 15-19 may have moderate to severe depression, and 20-27 may have severe depression, has proven validity for application in Chinese adult and college student populations with an internal consistency coefficient of 0.854 and a retest reliability of 0.873.
Measured: baseline;5 weeks post-treatment
Change from baseline in Temporal Experience of Pleasure Scale
The Temporal Experience Pleasure Scale consists of anticipatory (TEPS-anti) and consummatory anhedonia subscales (TEPS-con) with lower scores indicating stronger anhedonia propensity. The Chinese version has demonstrated high internal consistence (Cronbach's alpha = 0.84) .
Measured: baseline;5 weeks post-treatment
Change from baseline in Toronto Alexithymia Scale
The TAS developed by Taylor et al. in 1994 was used, with 20 items on a 5-point scale ranging from "totally disagree" to "totally agree". The scale contains three factors, namely, Disorders of Affective Identification (DIF), Disorders of Descriptive Affect (DDF), and Extraverted Thinking, and the TAS was tested for high reliability and validity.
Measured: baseline;5 weeks post-treatment
Secondary outcomes (2)
The change from baseline in behavioral results of Incentive Delay task
The amplitudes of brain potentials of assessed by eventrelated brain potentials methods change from baseline after the treatment.
Measured: baseline; 5 weeks post-treatment change from baseline after the treatment
The change from baseline in event-related brain potentials during Pain empathy task
The amplitudes of brain potentials of assessed by eventrelated brain potentials methods change from baseline after the treatment.
Measured: baseline; 5 weeks post-treatment change from baseline after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengqiong Yu, Anhui Medical University
- Investigators
- Wang Kai, MD, Study chair, Anhui Medical UniversityFengqiong Yu, MD, Study director, Anhui Medical UniversityKongliang He, MD, Study director, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355142
- Sponsor's protocol ID
- Y&H
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention
- ClinicalTrials.gov ID
- NCT05355142
- Acronym / sponsor ID
- Y&H
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brain Network Mechanism of Pain Empathy and Anhedonia in Patients With Depression by Group Problem Management Plus Intervention.
Detailed description
It is expected to collect 66 college students.
- Depressed college students；Healthy control: Inclusion criteria: 1) college students; 2) PHQ-9 > 4 points; 2) After informing the content of the study, agree to join the study, sign the informed consent form and accept relevant examination; 3) No major physical diseases in the past; Exclusion criteria: 1) lack of basic data; 2) Those who are currently diagnosed with depression and receiving psychotherapy; 3) Those who are unwilling to accept the inspection and quit halfway; 4) History of brain trauma, or accompanied by serious physical diseases, such as heart and liver dysfunction;
- Scale evaluation: 2.1 background information: gender, age, years of education, marriage and childbirth, place of residence (urban and rural), family economic situation (poor, general and good), family structure (core, single parent, reorganization and separation), self-rated learning pressure (high, general and low), whether he is an only child and whether he is a class cadre, etc. 2.2 depression assessment: Depression Screening Scale (PHQ-9), 2.3 symptom evaluation of loss of pleasure: time experience pleasure scale (TEPS); Loss of social pleasure (RSAs) 2.4 UCLA Loneliness Scale; TAS Alexithymia Scale; Chinese version of interpersonal response index scale (IRI)
- Experimental paradigm was measured before and after psychological intervention 3.1 Intensive delay First, the subjects were presented with a signal indicating that the cue was 400ms. After cue, the fixation point was 2250-2750 MS, and then the target stimulus square appeared. The presentation time was 160 ms to 260 Ms. The subjects are required to respond to the target stimulation key at the fastest speed. The time of random presentation of fixation is 1450ms. The feedback signal is given according to the results of the subjects' key response, and the presentation time is 1650ms. Finally, the fixation point was presented for 1200-1500ms; The whole paradigm includes two types of reward tasks; One is monetary reward and the other is social reward. Each task consists of 88 trials, resulting in a total of 176 trials. 3.2 Experimental paradigm of pain empathy In the experiment, the screen first presents a 400ms "+" fixation point, then presents a 400ms empty screen, and then presents a 1000ms picture stimulus. After the stimulus is presented, the empty screen is 1500 ~ 1700ms. The experiment consists of two tasks: ① pain judgment task, which requires subjects to judge whether the body owner in the picture will feel pain ② Left right judgment task: the task requires the subjects to distinguish the left and right limbs in the picture. The subjects also need to watch the picture carefully and make a judgment as quickly and accurately as possible。
- PM + (problem management plus) intervention is a psychological intervention of 1.5 hours each time for five weeks. Four strategies are mainly taught so that students can use them in daily life. PM + includes four core strategies: (1) decompression (breathing relaxation, mindfulness, etc.); (2) Problem management (coping strategies for practical problems); (3) Act by words, persevere, and emphasize behavior activation (mainly for the strategy of withdrawal of depressive behavior); (4) Strengthen interpersonal relationships (emphasis on strengthening interpersonal connections).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PM+ | Experimental | Behavioral: PM+Intervention once a week for a total of 5 weeks |
| control group | No intervention | –Just daily observation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- College students;
- PHQ-9 > 4 points;
- After informing the content of the study, agree to join the study, sign the informed consent form and accept relevant examination;
- No major physical diseases in the past;
Key exclusion criteria (4 listed)
- Lack of basic data;
- Those who are currently diagnosed with depression and receiving psychotherapy;
- Those who are unwilling to accept the inspection and quit halfway;
- History of brain trauma, or accompanied by serious physical diseases, such as heart and liver dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM+1 Brief introduction to PM+ \& NDA (5 min) Assessment-based review with PSYCHOLOPS (psychopomps psychology ) assessment (10 min) What is PM+ (20 minutes) Understanding Adversity (30 minutes) Stress Management (20 minutes) Closing the meeting (5 minutes) 2 General Review (5 min) Issue management (70 minutes) Stress management (10 minutes) Closing the meeting (5 minutes) 3 General Review (5 minutes) Problem Management (35 minutes) Take action and be consistent (35 minutes) Stress management (10 minutes) Closing the meeting (5 minutes) 4 General Review (5 minutes) Issue Management (20 minutes) Take action and be persistent (20 minutes) Strengthening Social Support (30 minutes) Stress management (10 minutes) Closing the meeting (5 minutes) 5 General Review (20 minutes) Staying Healthy (30 minutes) Imagining how to help someone (20 minutes) Looking ahead (15 minutes) Closing the de-briefing (5 minutes) | Behavioural | Group PM+ |
Primary outcome
Change from baseline in Patient Health Questionnaire
Time frame: baseline;5 weeks post-treatment
The four-level scoring of the PHQ-9 Depression Screening Scale, consisting of nine items with a total score of 0-27, where 0-4 is no depression, 5-9 may have mild depression, 10-14 may have moderate depression, 15-19 may have moderate to severe depression, and 20-27 may have severe depression, has proven validity for application in Chinese adult and college student populations with an internal consistency coefficient of 0.854 and a retest reliability of 0.873.
Change from baseline in Temporal Experience of Pleasure Scale
Time frame: baseline;5 weeks post-treatment
The Temporal Experience Pleasure Scale consists of anticipatory (TEPS-anti) and consummatory anhedonia subscales (TEPS-con) with lower scores indicating stronger anhedonia propensity. The Chinese version has demonstrated high internal consistence (Cronbach's alpha = 0.84) .
Change from baseline in Toronto Alexithymia Scale
Time frame: baseline;5 weeks post-treatment
The TAS developed by Taylor et al. in 1994 was used, with 20 items on a 5-point scale ranging from "totally disagree" to "totally agree". The scale contains three factors, namely, Disorders of Affective Identification (DIF), Disorders of Descriptive Affect (DDF), and Extraverted Thinking, and the TAS was tested for high reliability and validity.
2 secondary outcomes
The change from baseline in behavioral results of Incentive Delay task
Time frame: baseline; 5 weeks post-treatment change from baseline after the treatment
The change from baseline in event-related brain potentials during Pain empathy task
Time frame: baseline; 5 weeks post-treatment change from baseline after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Kai, MD study chair
Anhui Medical University
Fengqiong Yu, MD study director
Anhui Medical University
Kongliang He, MD study director
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PM+ in people with Treatment Resistant Depression and Problem Management Plus, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengqiong Yu, MD (0086055115955155423, yufengqin1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Patient Health Questionnaire (time frame: baseline;5 weeks post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.